Thiabendazole warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Warnings
If hypersensitivity reactions occur, the drug should be discontinued immediately and not be resumed. Erythema multiforme has been associated with thiabendazole therapy; in severe cases (Stevens-Johnson syndrome), fatalities have occurred.
Because CNS side effects may occur quite frequently, activities requiring mental alertness should be avoided.
Jaundice, cholestasis, and parenchymal liver damage have been reported in patients treated with MINTEZOL. In rare cases, liver damage has been severe and has led to irreversible hepatic failure. (See ADVERSE REACTIONS.)
Abnormal sensation in eyes, xanthopsia, blurred vision, drying of mucous membranes, and Sicca syndrome have been reported in patients treated with MINTEZOL. These adverse effects of the eye were in some cases persistent for prolonged intervals which have exceeded one year. (See ADVERSE REACTIONS.)
Thiabendazole should not usually be used as first line therapy for the treatment of enterobiasis. It should be reserved for use in patients who have experienced allergic reactions, or resistance to other treatments.
Precautions
General
MINTEZOL is not suitable for the treatment of mixed infections with ascaris because it may cause these worms to migrate.
Ideally, supportive therapy is indicated for anemic, dehydrated or malnourished patients prior to initiation of the anthelmintic therapy.
In the presence of hepatic or renal dysfunction, patients should be carefully monitored.
MINTEZOL should be used only in patients in whom susceptible worm infestation has been diagnosed and should not be used prophylactically.
Information for Patients
Because CNS side effects may occur quite frequently, activities requiring mental alertness should be avoided.
Laboratory Tests
Rarely, a transient rise in liver function tests has occurred in patients receiving MINTEZOL.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Thiabendazole has been used in numerous short- and long-term studies in animals at doses up to 15 times the usual human dose and was without carcinogenic effects. It did not adversely affect fertility in the mouse at 21⁄2 times the usual human dose or in the rat at a dose equivalent to the usual human dose. Thiabendazole had no mutagenic activity in in vitro microbial mutagen test, the micronucleus test and the host mediated assay in vivo.
Pregnancy Category: C
Reproduction and teratogenic studies done in the rabbit at a dose up to 15 times the usual human dose, in the rat at a dose equivalent to the human dose, and in the mouse at a dose up to 2 1⁄2 times the usual human dose, revealed no evidence of harm to the fetus. In an additional study in the mouse, no defects were observed when thiabendazole was given in aqueous suspension, at a dose 10 times the usual human dose; however, cleft palate and axial skeletal defects were observed when thiabendazole was suspended in olive oil and given at the same dose. There are no adequate and well controlled studies in pregnant women. MINTEZOL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from MINTEZOL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of thiabendazole for the treatment of Strongyloidiasis, Ascariasis, Uncinariasis, Trichuriasis and Trichinosis in pediatric patients weighing less than 30 lbs has been limited.
Geriatric Use
Clinical studies of MINTEZOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is metabolized almost completely by the liver, and the metabolites are known to be substantially excreted by the kidney, therefore the risk of toxicity may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16096slr033,16097slr026_mintezol_lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.